Is fresh whole blood (FWB) FDA-approved and intended for routine use?

Fresh whole blood (FWB) is not FDA-approved for routine use. The FDA regulates blood products and has established guidelines that classify different types of blood products based on their safety, efficacy, and intended use. While FWB can be beneficial in certain critical situations, especially in emergencies where rapid volume resuscitation is needed, its routine use is not standard practice due to several factors.

The composition of FWB can vary, and it contains a mix of red blood cells, plasma, and platelets, which may not provide the targeted benefits of more processed blood components such as packed red blood cells, platelets, or plasma. These processed components are specifically designed to treat various medical conditions and are better suited for regular clinical use.

In emergency settings, FWB might be utilized to quickly address severe hemorrhage or shock, but it is not the first choice in everyday medical practice. Therefore, it is important to note that FWB's use is restricted mainly to urgent circumstances rather than as part of standard medical procedures.